Key Changes to the Law on Circulation of Medicines
The legislative novelties are primarily aimed at harmonizing national regulation and rules established in the EAEU unified market.
On 15 February 2024, the President of the Russian Federation signed Decree No. 122 “On Improving the Procedure for Decision-Making on the Use of Inventions, Utility Models and Industrial Designs to Ensure the Economic Security of the Russian Federation” (“Decree”), which requires the Russian Government to form a Sub-commission on the use of inventions, utility models and industrial designs (“Sub-Commission”). The Sub-Commission will be formed under the Government Commission on Economic Development and Integration.
The Federation Council has approved the draft law No. 390361-8 “On Amending Article 1248 of Part Four of the Russian Civil Code” (the “Draft law”). The Draft law will shortly be signed by the President and will enter into force 10 days after its publication.
According to the Draft law, article 1248(2) of the Russian Civil Code will be amended with a provision on the possibility to reimburse the costs borne before Rospatent from the losing party.
On 1 January 2024 amendments to the Patent Regulations to the Eurasian Patent Convention (EAPC) came into force, affecting various aspects related to the implementation of administrative procedures aimed at obtaining a Eurasian patent for invention and industrial design.
The Russian Ministry of Industry and Trade has drafted amendments to Presidential decree No. 81 of March 1, 2022 (the "Decree"), which would extend the special procedure for transactions established by the Decree to transactions involving intellectual property. The draft is currently at the stage of anti-corruption expertise.
In accordance with the current version of the Decree, certain types of transactions with persons from "unfriendly" countries may be carried out only on the basis of permits issued by the Government Commission for Monitoring the Implementation of Foreign Investments in the Russian Federation (the "Government Commission").
On 15 November 2023 the Russian Supreme Court has published a review of court practice in cases involving the assessment of actions of trademark holders.
The review analyzes cases and circumstances in which the parties conduct is considered to be in bad faith or, on the other hand, in good faith.
On 4 November 2023 the decree of the Ministry of Industry and Trade No. 2701 dated 21 July 2023, which approved a new list of goods for parallel import and recognized the decree of the Ministry of Industry and Trade No. 1532 dated 19 April 2022 and all the amending decrees as null and void, comes into force.
By its Ruling of 25.09.2023 in case No. A40-185112/2022, the Ninth Commercial Court of Appeal ordered the pharmaceutical company Vertex, the right holder of a series of patents for the drug Trikafta (INN: Ivacaftor+Tezacaftor+Elexacaftor, Ivacaftor), to grant a simple (non-exclusive) license to the Russian pharmaceutical company MIK under Article 1362(1) of the Russian Civil Code (insufficient use of patents).
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